510(k) · Cleared
ClearedModification to Zymed Telemetry System, Model Easiview
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agilent Technologies · DQA Oximeter
Cleared on May 17, 2000 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- May 17, 2000
- Review
- 22 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 3 citing it directly.
- This deviceK001308 Modification to Zymed Telemetry System, Model EasiviewAgilent Technologies · 2000
- Descendant · cites it directly · 10 of its ownK031863 Carestation 126S VideophoneMotion Media Technology, Inc. · 2003
- Descendant · cites it directly · 5 of its ownK052608 Telephone Based BL Healthcare Remote Care Management System (RCMS)Bl Healthcare, Inc. · 2006
- Descendant · 2 generations on · 4 of its ownK093379 TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK033133 Telecare D.R. Server Software SystemHealthcare Vision, Inc. · 2004
- Descendant · 2 generations on · 2 of its ownK073710 Intouch Remote Presence Robotic System, Model RP-7Intouch Technologies · 2008
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K031863Carestation 126S VideophoneMotion Media Technology, Inc. · 2003 · cites it directly10descendants
- K052608Telephone Based BL Healthcare Remote Care Management System (RCMS)Bl Healthcare, Inc. · 2006 · cites it directly5descendants
- K093379TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010 · 2 generations on4descendants
- K033133Telecare D.R. Server Software SystemHealthcare Vision, Inc. · 2004 · cites it directly3descendants
- K073710Intouch Remote Presence Robotic System, Model RP-7Intouch Technologies · 2008 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001308 | Modification to Zymed Telemetry System, Model Easiview | Agilent Technologies | 2000 | — |
| +1 | K031863 | Carestation 126S Videophone | Motion Media Technology, Inc. | 2003 | — |
| +1 | K052608 | Telephone Based BL Healthcare Remote Care Management System (RCMS) | Bl Healthcare, Inc. | 2006 | — |
| +2 | K093379 | TCX-I-DV Remote Care Management System | Bl Healthcare, Inc. | 2010 | — |
| +1 | K033133 | Telecare D.R. Server Software System | Healthcare Vision, Inc. | 2004 | — |
| +2 | K073710 | Intouch Remote Presence Robotic System, Model RP-7 | Intouch Technologies | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031863 (Motion Media Technology, Inc., 2003) has gone furthest, with 10 descendants of its own.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
https://510kreport.com/device/K001308 · printed Nov 4, 2026
Cite this page
510(k) Report. “K001308: Modification to Zymed Telemetry System, Model Easiview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K001308
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026